On January 22-23, 2015, all-Ukrainian consultation meeting “Current issues of medicines’ production in the pharmacies” took place at the National University of Pharmacy

In the organization of meeting took part National University of Pharmacy (Department of Technology of Drugs, Department of Cosmetology and Aromology, Department of Pharmaceutical Chemistry, Department of Pharmacy-based Technology of Drugs named after D.P. Salo, Department of Social Pharmacy) and the State Service of Ukraine for Medications.

The meeting was headed by the First Vice-Rector of the NUPh Prof. A.A. Kotvitska, Head of the State Service of Ukraine for Medications M.F. Pasichnyk, Dean of the Faculty of Pharmacy of Lugansk State Medical University, Head of the Department of Technology of Drugs, Organization and Economics of Pharmacy O.P. Gudzenko, Major General of the Medical Service P.S. Syrota, Director of the SE “Ukrainian Scientific Pharmacopoeial Center for Quality of drugs” O.I. Hryzodub, Director of the State Department for regulation of wholesale and retail sale of medicines O.O. Krapyvnyi, Head of the NGO “Ukrainian Agency for Health technology assessment” K.L. Kosiachenko.

Among those present were registered 165 people – representatives of pharmacies and pharmaceutical organizations:

On January 22, 2015, there was held a plenary session of the meeting, where the following reports were presented:

“Current state and developing prospects of extemporal compounding in the pharmacies in Ukraine” (O.I. Tikhonov – Doctor of Pharmacy, Distinguished Professor of the NUPh, Honored Worker of Science and Technology of Ukraine, Laureate of the State Prize of Ukraine, Academician of the Ukrainian Academy of Sciences).

“Regulatory and technological aspects of production activity of the pharmacies in modern conditions” (T.G. Yarnykh – Head of the Department of Technology of Drugs of the NUPh, Doctor of Pharmacy, Professor, Honored Worker of Science and Technology of Ukraine, Laureate of the State Prize of Ukraine).

“Methodological recommendations on argumentation of tariffs” (A.S. Nemchenko – Head of the Department of Organization and Economics of Pharmacy of the NUPh, Doctor of Pharmacy, Professor, Honored Worker of Science and Technology of Ukraine).

“Fundamentals of organization of provision of the military bases and medical institutions with medical property in the extreme situation” (P.S. Syrota – Professor of the Department of Military Pharmacy, Major General of the Medical Service (in reserve).

“Modern requirements to the technology of medicines in the field conditions” (O.P. Shmatenko – Head of the Department of Military Pharmacy of the Ukrainian Military Medical Academy, Doctor of Pharmacy, Professor, Medical Colonel).

“Problematic issues of medical supply in the modern conditions of ATO” (V.I. Prudnikov – Head of the Medical Supply Office of the Military Medical Department of the Ministry of Defence of Ukraine, Medical Colonel (in reserve).

“Renewal of the practice of drug preparation in the conditions of pharmacies” (R.S. Korytniuk – Doctor of Pharmacy, Professor of the Department of Pharmaceutical Technology and Biopharmaceutics of the National Medical Academy of Postgraduate Education named after P.L. Shupyk)

“Modern scientific approaches to quality control of drugs made in pharmacies” (V.A. Georgiyants – Head of the Department of Pharmaceutical Chemistry of the NUPh, Doctor of Pharmacy, Professor).

“Optimization of extemporal production of drugs in pharmacies” (V.V. Gladyshev – Head of the Department of Drug Technology of the Pharmacy Faculty of Zaporozhye State Medical University, Doctor of Pharmacy, Professor).

“On the issue of the improvement of production of homeopathic medicines in pharmacies” (V.M. Tolochko – Head of the Department of Management and Economics of Pharmacy of IPhPQI, Doctor of Pharmacy, Professor).

“Modern problems and prospects for development of homeopathy in Ukraine” (R.G. Lytovchenko – Director of LLC “Homeopathic pharmacy”, pharmacist of the highest category).

In her welcome address First Vice-Rector of the NUPh, Honored Worker of Science and Technology of Ukraine, Professor A.A. Kotvitska greeted the participants of the meeting and wished everyone fruitful work. In his welcome address Chairman of the State Service of Ukraine for Medications M.F. Pashichnyk has emphasized the dynamic changes in the number of compounding pharmacies in Ukraine and the need to resolve issues that arise in their work.

During the meeting was heard the report of Prof. O.I. Tikhonov, devoted to the current state and development prospects of extemporaneous compounding in pharmacies of Ukraine and in the international pharmaceutical practice. The report provided analysis of legal regulations on technology and quality control of extemporaneous compounding.

Report Prof. T.G. Yarnyh covered the information on regulatory and technological aspects of production activity of pharmacies in modern conditions. Prof. T.G. Yarnyh told about work on the reedition of “Requirements for production” and “Handbook of extemporaneous formulation”, and described the inclusion of SPU 2.0 to general pharmacopoeial articles on extemporaneous preparations and changes of expiration dates of extemporaneous medicines.

In his report, Prof. A.S. Nemchenko drew attention of those present to the basic requirements, functional and role approach to the Good Pharmaceutical Practice and stressed the need for development of methodological recommendations to the argumentation of tariffs. There was presented the technique for determination of tariffs for production of extemporaneous preparations during the presentation.

Representatives of Ukrainian Military Medical Academy Prof. P.S. Syrota and Prof. O.P. Shmatenko told about the basics of organization of provision of military bases and medical institutions with medical property in extreme situations and highlighted modern requirements to the technology of drugs in the field conditions.

V.I. Prudnykov, Head of the Medical Supply Office of the Military Medical Department of the Ministry of Defence of Ukraine, highlighted the problematic issues of medical supply in modern conditions of ATO. He stressed the need for review of the stock list of the individual medical kit for military servicemen.

During the break, there was organized an excursion to the pharmacy №6 LLC “Leda” during which participants of the meeting had an opportunity to get acquainted with pharmacy activity and modern equipment for production of extemporaneous preparations.

In the second part of plenary session, Prof. R.S. Korytniuk in her report noted the need to develop extemporal formulation in Ukraine, in particular in the field pediatrics and geriatrics.

Professor V.A. Georgiyants highlighted modern scientific approaches to the quality control of drugs made in pharmacies. In particular, she highlighted the development of monographs for SPU and urgent problem of creation of methodological recommendations for validation of the methods for quality control of extemporaneous medicines.

Head of the Department Drug Technology of Zaporozhye State Medical University Prof. Gladyshev V.V. mentioned the main issues of optimization of extemporaneous drug production in the modern world.

Report of the Head of Practical Training and Employment Assistance Office Barkovska O.Ya. was devoted to the aspects of interaction of productive activities and theoretical training of the students and organization of Job Fair at the NUPh.

Prof. Tolochko V.M. in her report focused on the production of homeopathic medicines in pharmacies using the example of European Union.

Director of LLC “Homeopathic Pharmacy” Lytovchenko R.G. continued the topic of homeopathy and told about its current problems and prospects for development in Ukraine.

Questions of equipment for preparation, packing and sealing of dosage forms in compounding pharmacies was highlighted by Director of LLC SPC “Promfarm” Neronov M.O. During the report, there was demonstrated advanced equipment that can be used by pharmacies in the preparation of extemporaneous medicines.

Report of the Director of LLC “Leda” Demchenko O.V. was dedicated to the organization of compounding pharmacy and the ways to solve problematic issues of their work, and the rise in profitability.

On January 23, 2015, the second day of the meeting, sectoral discussions were held, in the course of which there were considered urgent problems of compounding pharmacies and their solutions; aspects of extemporaneous formulation in hospital conditions; some issues of the technologies of homeopathic medicines made in pharmacies.

Representative of LLC “Pharmacies of Medical Academy” (Dnipropetrovsk), Kruchek N.S. shared the experience of the usage of “RPO” software when dealing with extemporaneous preparations. The speech aroused a keen interest in purchase of this software.

Acting Head of Mykolaiv Regional Inspectorate for Quality Control of Drugs Shmalko O.O. highlighted the reasons for disappearance of compounding pharmacies and suggested the ways to optimize their work.

Deputy General Director for Quality Control ME “Pharmacy” (.Lugansk) Kozlov I.G. stressed the need to revise the expiration dates of internal half-finished products of the pharmacies, highlighted the problem of supply of pharmacy utensils and made suggestions for methodological recommendations “Requirements for production of non-sterile medicinal products”, “Requirements for production of sterile and aseptic medicinal products in pharmacies”.

Assoc. Prof. of the Department of Technology of Drugs of Lviv National Medical University Hudz N.I. dwelled on an issue of packing of extemporaneous medicinal products, microbiological control, peculiarities validation of the technology features extemporaneous drugs.

Prof. Georgiyants V.A. made a proposition to create methodological recommendations for validation of quality control of extemporaneous medicinal producats.

Director General of JSC “Eksimed” Ogorodniichuk O.S. proposed to cancel the registration of substances used by compounding pharmacies or to simplify the procedure.

Deputy Director of LLC “Istok plus” Kolenko V.F. drew attention to the need to specify the conditions of repacking of medicines in pharmacies (aseptic conditions) and special aspects of the choice of package for repacking.

Prof. Tolochko V.M. underlined the need to create a group that will coordinate the work and compile proposals of compounding pharmacies from different regions of Ukraine. He also proposed to create regional lists of basic (field) pharmacies, in which it would be possible to study and get experience in the organization of production function in extemporaneous manufacture of medicines.

At the end of sectoral discussions, Head of the State Service of Ukraine for Medications Pasichnyk M.F. expressed gratitude to the NUPh, in particular to the NUPh Rector, Member of the NAS of Ukraine, Doctor of Pharmacy, Professor Chernykh V.P., First Vice-Rector of the NUPh Doctor of Pharmacy, Professor Kotvitska A.A., representatves of the University, namely Prof. Tikhonov O.I. and Prof. Yarnyh T.G. and to all the speakers and participants of the meeting for active discussion of the current issues of drug production in pharmacies.

After a break, there were organized seminars on preparation of extemporaneous medicinal products at the Department of Technology of Drugs using modern mechanical equipment (hand capsule machine Feton (Belgium); homogenizer Silent Crusher M; laminar box Streamline SCR-2A1) led by Associate Professors Orlovetska N.F. and Dankevych O.S.

After that, participants of the meeting visited the Museum of History of Pharmacy of Ukraine.

PRESENTATIONS:

At the all-Ukrainian consultation meeting “Current issues of medicines’ production in the pharmacies” were presented the following projects:

Employees of the Department of Technology of Drugs of the National University of Pharmacy:

– Guidelines “Requirements for production of non-sterile medicinal products”;

– Guidelines “Requirements for production of sterile and aseptic medicinal products in pharmacies”.

– Reference book for extemporaneous formulation.

Employees of the Department of Organization and Economics of Pharmacy of the National University of Pharmacy:

– Methodological recommendation for determination of the tariffs for production of medicines in pharmacy.

Employees of the Department of Pharmacy-based Technology of Drugs named after D.P. Salo, Department of Cosmetology and Aromology, KhMAPE, SE “Committee on Folk and Alternative Medicine of the Ministry of Health of Ukraine”

– Guidelines “Requirements for production of non-sterile homeopathic medicinal products in pharmacies “

There were made and submitted to the State Service of Ukraine for Medications proposals to improve production of drugs in pharmacies regarding substances, means of mechanization, packaging, pharmacy utensils, requirements for facilities, quality control, pricing (determination of tariffs), etc.

Proposals on the subject can be sent to the National University of Pharmacy to the Department of Technology of Drugs: tl.2012@mail.ru